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Editors: Hoyt, Nicole, Liza and Cory. Contact us at intheloop@mayo.edu.

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May 20, 2014

Dissecting a Mayo Clinic clinical trial

By Hoyt Finnamore

Last week, the media world was all abuzz with the news of a certain clinical trial, and we may have given it a bit of attention ourselves. The clamor got us wondering what really goes on during Mayo's clinical trials and, as luck would have it, Minnesota Public Radio’s Cathy Wurzer was on the same quest and got some answers from Toni Kay Mangskau, Mayo Clinic clinical trials referral coordinator.

Mangskau tells MPR the typical clinical trial story goes like this: The patient may hear a news story about a clinical trial or a Mayo Clinic physician presents on it at a national or international conference. Once word gets out about the trial, a patient or a physician rings up Mayo Clinic.

In the beginning, Mangskau collects basic information such as a patient’s name, general demographic info, as well as their diagnosis and current treatment plan. Once she has this information, she begins seeking out available clinical trials at Mayo for that individual. Cancer patients have an especially long list of clinical trial options at Mayo, as Mangskau says that "at any given time, we have 300 actively enrolling studies for all cancer types."

After the phone interview, Mangskau says the next step in the clinical trial process is for a patient to be seen by a Mayo Clinic specialist.

Clinical trials at Mayo can last as long as six to seven years and are categorized into three separate phases. Mangskau shared with MPR the following chronological breakdown of how these phases typically work.

Phase 1: This is where they figure out the proper dose and best mode of treatment. If all goes well and Phase 1 testing is positive, the study can move to Phase 2.

Phase 2: This is where they look at the effectiveness and side effects of the treatment. Once again, if this phase is looking good, the study may be able to move onto Phase 3.

Phase 3: This is a larger study that compares standard treatments to newer treatments.

As you may recall, the patient who made clinical trial headlines last week, Stacy Erholtz, was in a Phase 1 clinical trial at Mayo Clinic when she was treated for multiple myeloma with a high dose of the measles virus.

Mangskau says that, in the case of newly diagnosed patients, "the slate is clean" and this may be the best time for them to participate in Phase 3. If patients are already receiving standard treatment, however, she says they may not be eligible to participate in Phase 3.

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